Integrated change management unit

ABSTRACT

An integrated system for managing changes in regulatory and nonregulatory requirements for business activities at an industrial or commercial facility. Application of this system to environmental, health and safety activities, and to food, drug, cosmetic, and medical treatment and device activities, are discussed as examples. The system: provides one or more databases that contain information on operations and requirements concerning an activity or area of business; receives information on regulatory and nonregulatory changes that affect operations of the business; converts these changes into changes in data entry forms, data processing and analysis procedures, and presentation (by printing, electronic display and/or distribution) of data processing and analysis results to selected recipients, without requiring the services of one or more programmers to re-key and/or reformat the items affected by the change; and implements receipt of change information and dissemination of data processing and analysis results using the facilities of the Internet.

RELATED APPLICATION INFORMATION

This application is a continuation of U.S. patent application Ser. No.14/932,728, filed Nov. 4, 2015, entitled “Integrated Change ManagementUnit,” which is a continuation of U.S. patent application Ser. No.13/909,482, filed Jun. 4, 2013, entitled “Integrated Change ManagementUnit,” which is a continuation of U.S. patent application Ser. No.12/912,375, filed Oct. 26, 2010, entitled “Integrated Change ManagementUnit,” which is a continuation of U.S. patent application Ser. No.12/098,154, now abandoned, filed on Apr. 4, 2008, entitled “IntegratedChange Management Unit,” which is a continuation of U.S. patentapplication Ser. No. 09/797,488, filed on Mar. 1, 2001, entitled“Integrated Change Management Unit,” now U.S. Pat. No. 7,356,482, whichis a continuation of U.S. patent application Ser. No. 09/215,898, filedon Dec. 18, 1998, entitled “Integrated Change Management Unit,” now U.S.Pat. No. 6,341,287. The disclosure of each of the foregoing isincorporated herein by reference in its entirety.

NOTICE OF COPYRIGHTS AND TRADE DRESS

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. This patent document may showand/or describe matter which is or may become trade dress of the owner.The copyright and trade dress owner has no objection to the facsimilereproduction by anyone of the patent disclosure as it appears in thePatent and Trademark Office patent files or records, but otherwisereserves all copyright and trade dress rights whatsoever.

BACKGROUND Field this Invention

The integrated management of information affected by regulatory changes,such as changes in environmental, health and safety laws, andnon-regulatory changes

Control of industrial and commercial activities by means of federal,state and local laws, statutes, ordinances and regulations(“regulations” herein) is endemic in the United States. Examples ofactivities that are regulated by such regulations include: environmentalhealth and safety (“EH&S”; Titles 7, 10, 29, 30, 40, 42 and 49 of theCode of Federal Regulations and related state and local codes);administrative procedures applicable to government personnel (Title 5);agricultural activities (Titles 7 and 9); creation, use, treatment anddisposal of nuclear materials (Title 10); conversion and distribution ofusable forms of energy, power and water (Titles 10 and 18); banking,financial and securities activities and foreign trade Titles 12, 15, 16,19 and 22); space and aeronautical activities (Title 14); commercialtrade practices (Title 16); food, drugs, cosmetics, medical treatmentsand devices (“FDCMTD”; Title 21); transportation of persons and cargo(Titles 23 and 49); housing and urban development (Title 24); firearmsproduction and trade (Title 27); workers compensation (Title 29); miningand related activities (Title 30); national defense activities (Titles15 and 32); navigation and navigable waters (Title 33); education (Title34); activities in and on parks, forests, public lands and other publicproperty (Titles 36 and 43); intellectual property activities (Title37); veterans' pensions and relief (Title 38); postal service activities(Title 39); public contracts and public property management (Titles 41and 48); public health (Title 42); emergency management and assistance(Title (44); grant of public welfare and assistance (Title 45);telecommunications (Title 47); and wildlife and fisheries activities(Title 50). Some of the most pervasive regulations concern EH&S andFDCMTD activities.

Generation and use of hazardous substances in the United States hasgrown steadily in the last 53 years and is now estimated to be over 300million metric tons per year. According to one definition, a “hazardoussubstance” is any substance or mixture of substances that may causesubstantial personal injury or substantial illness during or as aproximate result of any customary or reasonably foreseeable handling oruse, including reasonably foreseeable ingestion by children, if thesubstance: (1) is a toxic agent or reproductive toxin; (2) is corrosive;(3) is an irritant; (4) is a strong sensitizer; (5) is flammable,combustible or explosive; (6) is pyrophoric; (7) is a carcinogen,hepatotoxin, nephrotoxin or neurotoxin; (8) is an agent that acts on thehematopoietic system; (9) is an agent that damages the lungs, skin, eyesor mucous membranes; (10) is a compressed gas; (11) is an organicperoxide; (12) is an oxidizer; (13) is unstable, reactive orwater-reactive; (14) generates pressure through decomposition, heat orother means; (15) is sufficiently radioactive to require labeling assuch; (16) is a toy or other article intended for use by children andpresents an electrical, mechanical or thermal hazard; or (17) isspecially listed as a hazardous substance by a state or federal agencyhaving jurisdiction over such substances.

At the federal level, special purpose hazardous substance laws andregulations, focusing on a particular hazardous substance or narrowclass of such materials, have been applied for more than a century. In1866, a federal law regulating transportation and storage of explosiveand flammable materials was promulgated. This was followed in 1899,1910, 1938, 1944 and 1947 by passage of the Refuse Act, the firstInsecticide Act, the Food, Drug and Cosmetic Act, the Safe DrinkingWater Act, and the Insecticide, Fungicide and Rodenticide Act,respectively. In 1955 and 1966, the Clean Air Act and the FederalHazardous Substances Act appeared, respectively. Since 1969, the pace ofintroduction of new laws regulating hazardous substances has increased,and approximately 15 new major federal laws and voluminous regulationshave been introduced in this area. These laws often have overlappingjurisdiction and are not always consistent with one another. Severalstates, such as California, have passed their own hazardous substancelaws before the corresponding federal hazardous substance laws wereadopted. These laws still apply in those states and in many casessupersede their Federal counterparts. These laws statutes, ordinances,regulations and related constraints are constantly changing and requirecorresponding changes in data entry, data analysis and presentation ofthe results.

The Safe Drinking Water Act (“SDWA”), originally passed in 1944 andamended several times since then, covers all drinking water supplies inall states. Primary standards, to prevent adverse effects on humanhealth, and secondary standards and covering certain aesthetic effectssuch as odor and turbidity of processed drinking water, are set down interms of maximum permissible concentrations of specified contaminants inwater delivered to any public drinking water system. From a regulatorystandpoint, SDWA falls under the broader mandate of the Clean Water Act(“CWA”), whose ultimate goal is maintenance of the “chemical, physical,and biological integrity of the nation's waters.”

CWA, with its most recent amendment, the Water Quality Act (“WQA”) of1987, establishes mandatory effluent limitation guidelines for allfacilities which discharge waste into water bodies, or allow waste toenter and potentially contaminate subsurface water sources, likeaquifers. CWA created the National Pollutant Discharge EliminationSystem (“NPDES”) to regulate effluents, influents (waterborne wastesreceived by a treatment facility) and sludge. The primary enforcementmechanism of NPDES is the NPDES permit. CWA directs control authoritiesat the federal and state level to administer and enforce permitcompliance. NPDES permits include terms and conditions ranging fromrequired monitoring of point source discharges to the implementation ofcontrol technologies to minimize outfall.

The Clean Air Act (“CAA”), passed in 1955 and amended several timessince that time (most recently, in 1990), covers emission of pollutantsinto the ambient air and atmosphere. This may include hazardous wastesthat are liquid or gaseous when discharge occurs. National Ambient AirQuality Standards (“NAAQSs”) are set forth for seven chemicals orchemical groups: SO.sub.x, CO, NO.sub.x, O.sub.3, Pb, hydrocarbons andtotal suspended particulates. Additionally, emission standards are setforth for asbestos, beryllium, mercury and vinyl chloride. PrimaryStandards are set forth to protect human health, and Secondary Standardsare set to protect or limit damage to other entities, such as flora,fauna and personal and real property. The federal government in effectdelegates responsibility to achieve these standards to the individualstates, which are required to present and implement State ImplementationPlans to achieve the target air quality standards in various identifiedair basins in the states.

The primary enforcement mechanism of CAA is the CAA permit. Permitscovering emission source construction, modification, and operationfollow the NPDES scheme, adopting strict measures for controlling andreducing emissions of airborne waste at the source. CAA permits includeterms and conditions ranging from the application of abatement devicesand other control technologies for emission reduction, to requiredmonitoring at all source emission point sources and non-point sources(i.e., fugitive emission locations). Permits based on economic incentivestrategies, such as marketable emission allowances, were added to thefederal regulatory program maze under the 1990 amendments. Althoughthese additions were intended to stimulate compliance via market-basedvehicles (like emission allowance futures trading), these permits havenot, as yet, been broadly implemented.

The Toxic Substances Control Act (“TSCA”), originally passed in 1965,together with the Federal Hazardous Substances Act (“FHSA”) passed in1966 and the Resource Recovery Act (“RRA”) passed in 1970, were theinitial federal laws governing generation and handling of toxic andother hazardous substances. Most provisions of the RRA and the FHSA havebeen incorporated in the Resource Conservation and Recovery Act,discussed below. Under TSCA, the Environmental Protection Agency(“E.P.A.”) reviews any chemical substance that is or will be produced insufficient quantity that it may cause significant acute or chronic humanexposure. Testing is performed with respect to human health and theenvironment and focuses particularly on possible risk of serious harm tohumans from (1) cancer, (2) genetic mutations and (3) birth defects. Ifthe EPA finds that the risk to human health or to the environment issufficiently great, the EPA may: (1) limit the amount of the chemical tobe manufactured or used; (2) prohibit a particular use; (3) requireplacement of warning labels on all containers of the chemical; (4)require placement of public notices of use; and (5) regulate commercialuse and/or disposal of the chemical.

Any person, including a company, that manufactures or imports more than10,000 pounds or more of a chemical named on an E.P.A. ChemicalSubstances Inventory List is subject to the reporting requirements underTSCA. These reporting requirements include: (1) updating of a list ofall chemicals present on a site, at four-year intervals or morefrequently; (2) submission (to the E.P.A.) of a Pre-manufacture Noticeand relevant test data for any new chemical, at least 90 days beforemanufacturing or importing the chemical; (3) submission of a Notice OfIntent To Import or To Export a listed chemical, within seven days afterentering into a contract to import or export the chemical, if thechemical is known to be mutagenic, teratogenic or carcinogenic or isknown to cause chronic health or environmental problems; (4) reportingof a significant new use for a chemical already on the E.P.A. list; (5)reporting of known significant adverse reactions caused by handling ordischarge of any chemical used by the reporting entity; (6) submissionof any unpublished health and/or safety studies on certain chemicalsused by the reporting entity; (7) notification of any substantial riskof injury to human health or the environment, due within 15 days afterthe reporting entity first receives information on the risk; (8)submission of information on production of, use of and exposure tocertain chemicals to an Interagency Testing Committee for analysis bythe Committee; (9) submission of specified comprehensive information ona fixed format reporting form; (10) submission of results of tests, ifany, performed by the reporting entity on certain hepta-halogenateddibenzo-p-dioxins and dibenzofurans, within 90 days after a test, if apositive result is obtained; and (11) submission of a Notification ofPCB Activity form by any storer, transporter or disposer ofpolychlorinated biphenyl (“PCB”) waste. TSCA also sets forth certainrequirements for labeling of, disposal of and recordkeeping for certainchemicals, such as PCBs.

The Occupational Safety and Health Act (“OSHA”), passed in 1970, coversthe conditions under which employees work. The regulations issued underOSHA make this Act among the most detailed of all workplace laws. Therelevant parts of OSHA prescribe standards for the protection andwelfare of employees exposed to workplace hazards. An employer mustestablish a written hazard communication plan to advise its employees ofhazards associated with chemicals the employees handle, and incorporateinto this plan the use of container labels, warning signs, MaterialSafety Data Sheets (“MSDSs”) and training programs. The centerpiece ofthe OSHA Hazard Communication Standard is the MSDS, required for eachhazardous substance manufactured or used on the site. The MSDS includesall relevant information pertaining to a hazardous substance, from itsingredients to physical properties, health hazards, exposure limits,storage incompatibilities, safe handling and use precautions and muchmore. An employer must report, within 48 hours, any incident thatresults in a fatality, or in hospitalization of five or more employees.The OSHA Log and Summary of Occupational Injuries and Illnesses form isused to record all work-related injuries and illnesses for each calendaryear. Many such records must be maintained by the employer for theduration of employment of an employee, plus 30 years. An employer mustdevelop and implement a written emergency plan and make the planavailable in the workplace, whenever an OSHA standard requires it. Anemployer must also develop and implement a written safety and healthprogram and a medical surveillance program for employees involved inhazardous waste operations, including emergency response procedures.

The Occupational Health and Safety Administration (“O.S.H.A.”) under theDepartment of Labor (D.O.L.) develops and enforces all OSHA standards.The O.S.H.A. primary enforcement activity is the inspection, or auditprocedure. Facilities covered by one or more OSHA standard are subjectto voluntary (routine) inspections, as well as non-voluntary inspectionsbased on a warrant to search.

The Hazardous Materials Transportation Act (“HMTA”), passed in 1974, isadministered jointly by the Department of Transportation (“D.O.T.”),established in 1966, and the E.P.A., established in 1969. The HMTA setsforth 15 hazard classes of materials (e.g., flammable liquids, highexplosives, poisons) plus five classes of “other regulated materials”and sets forth laws and corresponding regulations on: (1)identification, listing, labeling and placarding of these hazardoussubstances; (2) recordkeeping requirements for handling these hazardoussubstances, including Uniform Hazardous Material Manifests for shipmentof hazardous wastes; (3) requirements for generators and transporters ofhazardous substances and for owners and operators of specially definedtreatment, storage and disposal facilities (“TSDFs”) for these hazardoussubstances; (4) permit and pretransport notification requirements andtransportation routing for all facilities that generate or transportthese hazardous substances; (5) requirements for tracking the movementof these hazardous substances; (6) containers to be used for transport;(7) incident notification and other procedures for handling andreporting accidental and intentional discharges of hazardous substances;and (8) testing and standards for operators of transport vehicles forhazardous substances. Hazardous wastes and other hazardous substancesare not distinguished under the HMTA. A “generator” of a hazardous wasteis defined simply as “any person whose act first causes a hazardouswaste to become subject to regulation”. Transportation modes coveredinclude movement of the hazardous substance by air, rail, water andhighway. The D.O.T. is authorized to inspect generator and transporterfacilities, vehicles and records to insure compliance.

The Resource Conservation and Recovery Act (“RCRA”), passed in thepresent form in 1976, was originally part of the Clean Air Act, passedin 1966. The RCRA establishes “cradle-to-grave” responsibility forhazardous solid waste handled by a generator, by a TSDF operator, or bya hazardous waste transporter or recycler. Under RCRA, a solid waste isa “hazardous waste”, if: (1) the waste arises from specifiedmanufacturing practices; (2) the waste is one of a group of specifiedwastes; (3) the waste contains any of a group of specified chemicals; or(4) the waste has specified toxicity, chemical reactivity, ignitabilityor corrosive characteristics. Household wastes are generally exemptedfrom RCRA coverage. Generators of more than 1,000 kilograms per month ofordinary hazardous wastes or of more than 1 kgm per month of extremelyhazardous waste must operate under a RCRA permit covering registration,container labeling, recordkeeping and other requirements. “Smallquantity generators”, who generate 100-1,000 kgms per month of hazardouswastes and no more than 1 kgm per month of extremely hazardous wastes,are covered by simpler requirements. Generators of still smaller amountsof the hazardous wastes or the extremely hazardous wastes are oftenexempt from regulation under RCRA.

The goals of RCRA include: (1) protecting the health, safety andenvironment of the public; (2) regulating the generation, treatment,disposal and storage of hazardous wastes; (3) reducing environmentalpollution from waste disposal; (4) encouraging recycling and/or re-useof hazardous wastes; and (5) eliminating certain landfill and othersolid waste disposal practices. A Notification of Hazardous WasteActivity must be submitted by a generator, transporter or operator of ahazardous waste TSDF to apply for an E.P.A. identification number andfor any applicable E.P.A. permits for on-site treatment, storage ordisposal. Hazardous waste generators are required to conduct their ownstudies to determine if a specific hazardous waste can be treated toreduce its volume or toxicity, with records of such studies beingsubmitted each year to the E.P.A. and being maintained for three years.

A Uniform Hazardous Waste Manifest, developed by the E.P.A. under RCRAand under HMTA, must be used by persons who transport hazardous wastefor off-site treatment, storage or disposal, and a copy of each Manifestmust be maintained as part of a facility's operating record. Owners oroperators of a TSDF who receive hazardous waste without a properManifest must submit an Unauthorized Waste Report to the E.P.A. within15 days after such an incident occurs. Upon closure of a hazardous wastefacility, records of hazardous waste disposal and the amounts thereofmust be submitted to the E.P.A. and to local land use controlauthorities.

A hazardous waste generator must demonstrate that it has the financialability to cover liability claims involving sudden or non-suddendischarges from the facility. An owner or operator must monitor andinspect all on-site tanks that treat or accumulate hazardous waste. Aspill or other discharge must be reported to the National ResponseCenter (“N.R.C.”) within 24 hours after the incident occurs, and adetailed report on such incident must be submitted to the E.P.A. within30 days after the incident. RCRA is enforced concurrently withapplicable state statutes.

The Comprehensive Environmental Response, Compensation and Liability Act(“CERCLA”) was passed in 1980 in response to the discovery of severalhazardous waste disposal sites that would have to be cleaned up atgovernment expense. CERCLA was intended to: (1) provide a system foridentifying and cleaning up chemical and hazardous substance releases;(2) establish a fund to pay for cleanup of release sites, where thoseresponsible cannot or will not pay for the cleanup; and (3) enable thefederal government to collect the costs of cleanup from the responsibleparties. The federal government set aside $1.8 billion in the firstSuperfund for hazardous waste site clean-up purposes. CERCLA includes onits hazardous substance list all hazardous wastes under RCRA, allhazardous air pollutants regulated under the CAA, all water pollutantsregulated under the CWA, and most substances regulated under TSCA.

In 1986, the Superfund Amendments and Reauthorization Act (“SARA”) addedanother $6.2 billion to the Superfund for clean-up purposes SARA alsoenacted Community-Right-to-Know requirements into law. Title III of SARAcontains the Community Right-to-Know requirements and provides for: (1)Emergency Response Planning; (2) Accidental Release Notification; (3)Facility Hazardous Substance Inventory Reporting; and (4) Facility ToxicSubstance Release Reporting.

Sections 301-303 of Title III enacted the requirement for EmergencyResponse Planning. Emergency Response Planning as enacted by SARArequired the creation of committees at both State (State EmergencyResponse Committee, or S.E.R.C.) and Local (Local Emergency PlanningCommittee, or L.E.P.C.) levels. Owner/operators of facilities withspecified hazardous substances on site in quantities in excess ofspecified thresholds are required to prepare and submit EmergencyResponse Plans to the L.E.P.C. having jurisdiction over the facility.Elements of the facility Emergency Response Plan include: (1)identification of Emergency Response procedures to be used for action onthe site and for areas surrounding the site; (2) identification of afacility coordinator for implementing the plan; (3) procedures to beused during emergencies for notifying authorities and potentiallyaffected parties; (4) methodology for determination when a release hasoccurred and the probable area and population at risk; and (5)description of Emergency Response assets that are in place as well asthe contact point for the Emergency Response assets.

Section 304 of Title III requires preparation and filing of anAccidental Release Notification report whenever an accidental release ofa specified hazardous substance occurs in which (1) the substancecrosses the facility boundaries or is released in transport on publicroads, and (2) the release amount exceeds specified thresholds. Thisreport must address: (1) actions taken to contain or respond to therelease; (2) any known or anticipated acute or chronic health risksassociated with the release; and (3) advice regarding medical attentionrequired for any exposed individuals.

Section 311 and 312 of Title III provide for facility hazardoussubstance inventory reporting. Facility hazardous substance inventoryreporting is required if substances for which an MSDS is required underOSHA are present in quantities in excess of specified thresholds.Facilities subject to hazardous substances inventory reportingrequirements must: (1) produce a listing of specified hazardoussubstances present at the facility or an MSDS for each specifiedhazardous substance; and (2) an emergency and hazardous chemicalsinventory report form. Both reports (listing/MSDS and inventory report)must be submitted to the following agencies: (1) L.E.P.C.; (2) S.E.R.C.;and (3) local Fire department.

Section 313 of Title III requires the E.P.A. to establish an inventoryof toxic chemical emissions from certain facilities. To do so, theE.P.A. requires owners and operators of facilities that manufacture,import, process, or use specified toxic chemicals to report annuallytheir releases of those chemicals to any environmental media. Releasesto air, water, and land, and releases to off-site locations such aspublicly owned treatment works or hazardous waste disposal sites, mustbe estimated and reported under Section 313. Both routine and accidentalreleases must be reported. Facilities must report even if their releasescomply with all environmental laws and permits.

The Pollution Prevention Act (“PPA”), passed in 1990, requires hazardouswaste generators and other similar facilities that manufacture, import,process or otherwise use listed toxic chemicals to annually reportreleases of any of these chemicals to any environmental medium(atmosphere, water, soil and biota). For each listed chemical that isreported, the generator must provide: (1) the quantity of the chemicalthat is released (before recycling, treatment or disposal) into a wastestream and the change, if any, from release in the preceding year; (2)the quantity of the chemical, if any, that is recycled or treated at thefacility or elsewhere, the percentage change from the preceding year andthe method(s) of recycling or treatment used; (3) the source reductionpractices adopted by the generator and the quantitative method(s) usedto monitor these practices, with these practices being reported in thecategories of (a) equipment, technology, process or proceduremodifications, (b) reformulation or redesign of the products, (c)substitution of input materials and (d) improvement in management,training, inventory control, materials handling or other administrativepractices; (4) quantities of the chemical, if any, that are released inone-time events not associated with production processes; (5) quantitiesof the chemical expected to be released into a waste stream or to berecycled in each of the two immediately following years; and (6) a ratioor other quantitative comparison of production of the chemical betweenthe current and preceding reporting years. Much of this informationwould be reported on a revised Form R under SARA Title III for eachlisted chemical.

Various attempts have been made to manage regulatory compliance, but nosolution has been developed before that provides a comprehensive,integrated framework for (1) absorbing business changes into theapplication and database without affecting the integrity of the system,(2) automatically making application and database changes usingintelligent agent routines, (3) managing technical and businesscontent-related functionality using metadata tables rather than relyingon traditional programming methods. Other workers have createdregulations databases, document management systems and other partialsolutions for tracking changes in, and compliance with, regulations andsimilar requirements, but these partial solutions have not addressed theeffects of change across an integrated database application or across anintegrated framework of technical functions. These partial solutionsalso do not provide a “closed loop” approach to identifying changesusing intelligent network agents, recommending modifications to thebusiness content, and automatically effecting modifications in thesystem without the use of programmers and/or programming.

One recurring problem with any database that frequently changes ismaintenance of the database as current. Where a database depends uponthe current regulatory state, as where an EH&S database is beingmaintained by a conventional approach, continual reprogramming of thedatabase software is required to reflect a constant stream of changes.This approach is not cost effective and, in effect, mortgages thedatabase maintainer's future.

What is needed is an integrated change management system for a selectedarea of commercial or industrial activity that: (1) provides one or moredatabases having all relevant available information, including knowledgeof regulatory and non-regulatory information and changes, used inconnection with the activity; (2) facilitates sharing of thisinformation between databases; (3) generates and archives records ofsoftware system versions used for data entry, reporting, processing,analysis and results presentation, and changes to these versions; (4)generates all documents and reports required for compliance underapplicable regulations, laws and statutes; (5) provides screen images,and appropriate changes to these images, that implement data entry,processing, analysis, reporting and results presentation; and (6) allowsentry of the changes and modification of the affected data entry forms,report forms, views, screen images, functions, processes and formulas,without requiring (re)programming of the underlying software.

DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically illustrates the relationship of four layers thatare the primary components of the invention.

FIG. 2 is a flowchart illustrating use of the invention to respond toone or more relevant changes found by an intelligent agent on a network.

FIGS. 3, 4A, 4B and 5 display metadata tables that are important inoperation of the metadata layer.

FIGS. 6 and 7 are flow charts comparing procedures for creating a dataentry form, using the invention (FIG. 6) and using a conventionalapproach (FIG. 7).

FIGS. 8-19 are examples of screen images used in application of theinvention to EH&S activities.

DETAILED DESCRIPTION Summary of the Invention

These needs are met by the invention that, in one integrated system, (1)provides one or more databases that contain information on operationsand requirements concerning an activity or area of business; (2)monitors and evaluates the relevance of information on regulatory andnon-regulatory changes that affect operations of the business and/orinformation management requirements; (3) converts the relevant changesinto changes in work/task lists, data entry forms, reports, dataprocessing, analysis and presentation (by printing, electronic display,network distribution and/or physical distribution) of data processingand analysis results to selected recipients, without requiring theservices of one or more programmers to re-program and/or recode thesoftware items affected by the change; and (4) implements receipt ofchange information and dissemination of data processing and analysisresults using the facilities of a network, such as the Internet

Description of Best Modes of the Invention

The invention provides an integrated system for managing data that is,or can be, constantly changing, because of changes in regulations, inthe business environment, in technology and in any other factor thatmaterially affects operations and/or information management requirementsof a particular business. Without an integrated method for automaticallyhandling such changes, a developer or user of software that tracksbusiness operations must continually rewrite part or all of the softwarein order to accurately and fully reflect these changes, usually at greatexpense and effort and with little hope for relief.

This invention monitors, responds to, and incorporates changes in,federal, state and local laws, statutes, ordinances and regulations(referred to collectively herein as “regulations”) and changes intechnology in one or more regulated areas of commercial activity, suchas environmental health and safety (EH&S), and food, drugs, cosmetics,medical devices and treatments (“FDCMTD”). Initially, making applicablelaws and regulations available and searchable gives rise to datamanagement requirements and to development of one or more suitabledatabases. Implementation of a database carries with it questionsconcerning initial investment, maintenance and upgrade costs, integrityand security concerns. When one or more of the applicable regulationschanges, this affects the data management requirements and theunderlying database(s) and any existing software linkages betweenrelated database structures. The invention provides a relativelyseamless system for creating robust solutions without the use ofprogrammers and/or programming, (2) monitoring and assimilating businesschange into business solutions rapidly, without (re)programming, and (3)providing business solution customization and extensibility withoutimpacting the integrity or security of the system.

The system operates at four layers, as illustrated in FIG. 1: (1) achange management layer 11 that includes one or more change agents that“cruise the Web” and identify and bring to the user's attention relevantregulatory and non-regulatory changes found on the Web that may affect auser's business; (2) a Java data management layer 13, a user interface,built using the Java language, that applies metadata attributes tobusiness and business-change related data (regulation-based ornon-regulation-based); (3) a metadata layer 15 that provides and/ordefines data about every feature of the user interface including,without limitation, tools, worklists, data entry forms, reports,documents, processes, formulas, images, tables, views, columns, andother structures and functions; and (4) a business content layer 17 thatis specific to the particular business operations of interest to theuser.

Within the Java management layer, configuration tools take the place ofa programmer and define various end user functions in terms of metadata,and metadata definitions are used to implement the desired end userfunctions. Within the metadata layer, the relevant items (data entryforms, etc.) in the business content layer are defined, regulatory andnon-regulatory changes in these items are implemented, and accessthereto is provided. Within the business content layer, the relevantitems are stored (and changed, as appropriate) for the specific businessoperations of concern to the end user. A business area or grouping inthe business content layer is referenced and described by the metadatalayer to enable management by the data management layer. The system'sfour layers, plus the Configuration tools and the End User tools, areillustrated in FIG. 1.

The invention includes an integrated framework of technical functionsfor tracking and managing regulatory compliance, non-regulatoryrequirements and other change-intensive business activities. Theinvention provides a cost-effective approach for absorbing database andapplication changes that arise from changes in regulations, policies,procedures, processes, materials, and similar factors. The integratedframework of the invention is divided into two main groupings, ChangeConfiguration functions and End User functions. The Change Configurationfunctions support creation and change of End User functions through avariety of flexible and intelligent manual routines, such as intelligentagents, screens, fields, reports, documents and logic that can bechanged without requiring programming skills. The End User functionssupport business-related activities, such as data entry, data analysis,document generation, document distribution and reporting, that areutilized by a typical business user.

The metadata architecture is unique in that it stores all of theinformation used to create the front-end business application and managethe back-end business database. Unlike “hard-coded” systems, in whichbusiness functionality and content is managed by explicit lines of code,the metadata architecture of the invention is entirely data-driven.

Regulations and technical requirements are constantly changing in theUnited States. Regulatory changes are recorded and posted for referencein different media, including paper, microfiche and electronic media.The internet is one source of information on regulatory change that isboth prompt and cost-effective. The following example illustrates how achange, made to a regulation, is identified on the Internet andincorporated and managed by the invention.

A. Example

Assume that a federal regulation, governing disposal of hazardous wastein landfills, is amended so that the regulation now requires analysis,reporting and record keeping of landfill samples. Part of the changelanguage addresses what landfill sample information must be collected,including landfill type, landfill cell, parameter(s) sampled,identification of chain-of-custody, and laboratory results. The changeis posted in the Federal Register and becomes promptly available as ahard copy (paper) and electronically, on the Internet.

The invention begins tracking change using one or more intelligentagents (“IA's”). An “intelligent agent” is a specialized program thatresides on a network, or at a server as an applet, and can makedecisions and perform tasks based on pre-defined rules. Preferably, twoor more IA's used by a business will have sufficiently differentassignments that at most modest overlap occurs between the IA's. An IAfunction is part of the Logic Menu, which is discussed subsequently.

A change made to landfill waste regulations is identified by an IA onthe Internet, and the relevant change information is routed to aselected metadata table in the invention. The change informationincludes one or more of five recommendations: (1) create a new WorkList;(2) change one or more data entry forms; (3) create one or more newreports; (4) create a new process; and (5) add one or more new documentimages. Configuration Users can choose to automatically configure thepreceding recommendation based on a set of default conditions, or canmanually implement the configuration using a configuration toolkit.

A new WorkList is created manually in a Set Up WorkList function,discussed subsequently, to guide an End User through the tasks involvedin recording a sample, tracking the sample through a chain-of-custody,printing a management report of all samples submitted for analysis,preparing and processing a government report, and printing or otherwisedistributing the government report on a required government form, or onthe Internet, as a document image. No workflow or task managementprogramming is involved in creating the new WorkList. An End User canselect the new WorkList in the WorkList function under the File menu andcan begin tracking the changing work and tasks.

The WorkList function serves a central role, offering a means forintegrating the various data management functions in what can becharacterized as a virtual, task-driven menu. The invention provides anintegrated user interface with all the functions necessary for managingbusiness data: data entry forms, reports, documents, processes,formulas, etc. The WorkList extends this user interface by allowingusers to set up lists of functions in the order that such functions aretypically used by an end user. FIG. 3 illustrates the importantstructures and relationships that allow such implementation. FIG. 3illustrates how worklist items can include modules (data entry forms,reports and documents), processes and sub-worklists. A user can createits own task-driven menu and adapt rapidly to change(s) and minimize oreliminate the cost of (re)programming.

A change to a data entry form is accomplished automatically, usingdefault assumptions. A Configuration User can automatically launch theconfiguration process from the Change Log, adding two new fields to theWaste Sample form, for ‘Landfill Type’ and ‘Landfill Cell.’ No forms(re)programming is required in adding the two new fields to the WasteSample form. An End User sees these changes to the form(s) the next timeone of the Waste Sample forms is opened in the Data Entry Form under theFile Menu.

A new Report is created automatically, using the View Builder and theReport Builder functions to track all samples sent for analysis, samplestatus and sample turn-around time. The Configuration User uses ViewBuilder to join and create new views and sample reporting tables, suchas Samples, Laboratory Samples and Sample Status. The Configuration Useruses Report Builder to sequence the fields in the report, specifydesired fonts, and create a title for the report. No report(re)programming is required in creating the view or report. An End Usercan select and print the new report within the Report function.

A new process is created manually, using the Advanced Query Builder andSet Up Processing functions. The new process may determine which samplescontain contaminants with levels above a regulatory limit or threshold.The Configuration User uses the Advanced Query Builder to create a viewthat joins Sample Results and Regulatory List Results and contains logicfor comparing one value to another. The Set Up Processing functiondefines the new view as a process that can be scheduled and that willreturn results each time the function is executed or launched. No SQL,PL/SQL or other type of (re)programming is required to create the newview or process. An End User can select, schedule and execute the newprocess using the Process function in the Logic Menu.

A document image is created manually in the Document Builder function toprovide regulatory report data on the required government form. TheConfiguration User imports the image from the Internet and maps thefields on the form to columns in a database. No (re)programming isrequired in mapping the document(s) to the database. An End User canselect the Document Image function from the File Menu and visuallyexamine the results of the report process on the government form.

The system uses a standard interface, a part of the invention, that isbased on a multi-tier, server-based, Web-enabled computing model thatdoes not require (re)programming to respond to changes in the receiveddata. A system created using the invention is dependent upon, and drivenby, the supporting metadata. The metadata describes the various systemcomponents, using a business-like terminology, and replaces thefront-end or desktop portion of a user interface. Three main componentsof the interface portion of the invention are a Web server, a databaseserver and a Java-enabled browser that uses TCP/IP or a similarprotocol.

A primary requirement of the invention is to allow a reasonably skilledend user to produce a set of relevant data through the interface,without requiring use of a programming or database manipulation language(DBML), such as SQL.

Each of the four layers is discussed in more detail in the followingsections.

B. Business Content Layer

The business content layer includes business knowledge, logical designs,physical designs, physical structures, relationships, and dataassociated with a selected area of business activity. A business areacan be a functional field within an organization, such as finance orhuman resources, or a particular type of business, such as printing or a(specialty) food business, for which business-related data must beaccumulated and managed. The business content layer is defined by andreferenced in the metadata layer so that the necessary objects, tables,columns, relationships, functions, procedures and data can be read andupdated by the Java data management layer. The business content layermay be characterized as a business content database.

C. Metadata Layer

The metadata architecture is created using Oracle or a similar databasesystem. The metadata model has two main components, a business contentdata dictionary and an application component. The data dictionarydescribes or defines the data elements of the application system and thebusiness content layer and how a data element is recorded and managed atthe database management system (DBMS) level. The application componentprimarily records procedures for manipulating business information usingdata entry forms, worklists, processes, documents, reports and businesslogic.

The most important aspect of the server-based, programming-free model isthe system's ability to create, change and (re)configure the applicationsystem at one location and to promptly make the modified applicationsystem available elsewhere within the enterprise as well. This approachalso eliminates the need to write new code or to modify existing codeand eliminates the need for (re)compiling and creating executableinstructions and updating every affected user's computer within theorganization. This approach is implemented using intuitive,user-friendly, dialog-based screens and using small code segments todefine business logic.

FIGS. 4 and 5 illustrate some of the relationships between several ofthe metadata tables that are part of the metadata layer. The GreenSuiteImage table 31 stores application images for use with menus that arepart of the system. The imagelink table 32 records the links betweenmodules and images. The image source table 33 provides image files foruse in the system. The View column table 34 holds the columns definedfor all views in the system. The View table 35 holds the definition of a“View.”

The View Business Area table 36 records information about business areaViews in the system. The Business Area table 37 holds the definition ofbusiness areas and forms a high level grouping of various businessfunctions that can be implemented using the system. The business processbusiness area table 38 records information about business area processesin the system. The business area worklist table 39 records worklists forthe business area. The View parameter table 40 holds the parameters thatdefine all views in the system.

The View group table 41 records information about group Views in thesystem. The group table 42 holds the various user groups defined in thesystem. The group menu table 43 stores the menu items that areaccessible by user groups. The menu table 44 holds the menu items andtheir hierarchical structures in the system. The user table 45 holds theuser names defined in the system.

The group module table 46 stores the modules that are accessible by usergroups in the system. The business area module table 47 records modulenames for every business area. The language table 48 provides differentlanguage definitions for use in the system. The menu title table 49provides the menu titles for the system. The business process table 50provides the definitions and business logic of the processes definedwithin the system, to support reporting activities.

The report group table 51 provides details for the report group. Thereport matrix table 52 provides the definitions of matrix reports. Themodule item table 53 provides the definitions and business logic ofindividual data elements for every data entry form, report and documentdefined in the system. The module table 54 provides the definition andbusiness logic for all data entry forms, reports and documents createdwithin the system. The report parameter table 55 records the parametersspecified for reports in the system.

The report trigger table 56 records the triggers specified for reportsin the system. The worklist item table 57 provides definitions of, andlinks to, modules launched from the worklist. The worklist table 58provides the definitions and logic for worklists that facilitate workflow for a business activity. The calculation profile table 59 providesthe definitions and logic to perform calculations related to data entryforms, for decision making and data input. The calculation profile valuetable 60 records the calculation profile variable values.

The module formula table 61 provides the formulas used by the modules inthe system. The module formula argument table 62 provides the formulaarguments used in the module. The module trigger 63 provides the generictriggers specified for modules in the system. The output item table 64provides details for the document module items. The output data sourcetable 65 provides details for the document module items data source.

The related module table 66 provides the links between modules in thesystem. The formula table 67 provides the definitions of formulas usedin the system. The formula argument table 68 records the arguments forall formulas used in the system. The table 69 maintains all theapplication table definition details. The output data item table 70provides details for the document module items.

The calculation profile variable table 71 records the calculationprofile variables. The column table 72 records the data elements ofevery table recorded in the table 69. The output group property table 73maintains the details of the application table columns. The module eventtrigger table 74 provides the event triggers specified for modules inthe system. The module event trigger step table 75 provides the eventtrigger steps specified for modules in the system. The output templatetable 76 provides the document template details.

With reference to FIG. 5, the constraint column table 81 providesindividual data elements for the business rules. The constraint table 82provides the business rules defined at the database level for everytable in the application system, together with the meaning of each rule.The column table 72 is characterized in the preceding. The columnallowable value table 83 provides the business rules at a data elementlevel. The autofill table 84 records the automatic data transfer setup.The arc column table 85 provides data elements that are part of everyusually exclusive relationship in the system. The arc table 86 recordsthe mutually exclusive relationships in the system. The lookup table 87provides the lookup definitions for every child table in the system. Thetablename table 69 is characterized in the preceding. The object table88 holds the names of the database objects defined in the system. Theabout table 89 stores versions of, and copyright information concerning,the system. The datatype table 90 provides the datatype definitionsthroughout the system. The dependency tree table 91 provides theapplication and database hierarchy(ies). The color table 92 provides thecolor definitions for use in various tools.

D. Java Data Management Layer

The Java format is chosen as the basis for the data management layerbecause Java is an object-oriented language that is powerful, flexible,easily learned, multi-threaded, portable, and distributable over anetwork through use of a browser.

When an object-oriented language (OOL) is employed, once a particularkind of activity has been programmed for an object, that behavior can beshared with other like objects, rather than being reprogrammed each timea new like object is introduced. A future program or activity can“inherit” code from a program that presently exists so that code becomesreusable. One result of this is reduced (re)programming time and codedebugging time.

Java is powerful, in part because of the class libraries provided in thelanguage. For example, a programmer who wishes to place a special buttonon a screen can use qualities of a button provided with the JavaAbstract Window Toolkit, then add behavior to perform specific tasks.Java is also more easily learned than its closest predecessor, C++.Although much of the syntax of Java and C++ is the same, a Javaprogrammer doesn't have to deal with pointers and memory allocation, twoonerous features that are part of programming with C++.

Java, because it is multi-threaded, can handle two or more taskssimultaneously. For example, building part of a screen, displaying thepart of the screen, and pursuing the remainder of the screen-buildingactivity in a background thread gives an end user the impression thatthe screen is quickly ready for use.

A Java program, once written, can be run on any platform having a Javainterpreter so that Java is portable. Because compilation of a Javaprogram generates “bytecode”, not machine-specific runtime code,recompilation is not necessary when moving from one platform to another.The major browsers, Netscape Navigator and Internet Explorer, include aJava interpreter so that a user of those browsers can run Java code.

Traditional client-server applications require upgrades to a clientmachine whenever code changes are implemented, a daunting task in alarge network. Where Java applets are used, code is downloaded atruntime, insuring that the client has the most recent version of thecode. This allows easy deployment of Java code over the Internet, orover an intranet of an organization. The Java security model preventsunauthorized tampering with the client machine using non-authenticatedcode. By using Java, the invention disclosed here also becomesplatform-independent, portable, secure and easy to deploy over asuitable network, such as the Internet. A more extensive discussion ofJava is available at http//:www.javasoft.com.

The Java data management layer of the system provides a graphical userinterface for both the metadata layer and the business content layer,which allows a web browser user to communicate with the metadata andbusiness content layers on a server from anywhere in the world.

No part of the Java data management layer is programmed for specificbusiness content. Each procedure used by an end user is, or can be,tailored for specific business content and for specific user roles. Theend user's system may be (re)configured without programming and may bemaintained without programming.

The user interface is generated by the interpretation of the metadatalayer delivered to the Java data management layer. The relationshipbetween the business content layer and the Java data management layermay be characterized as a “data mapping,” with no hard-wired coding asis typical in a conventional program. “Data mapping,” as used here,refers to a mechanism that provides a correspondence between an item ina graphical user interface (GUI) and an item to be changed in thebusiness content layer.

The Java data management layer and thus what the end user sees isdefined only by the metadata and is generated as needed by a singleprogram that interprets what a form will look like. Flexibility ismaintained by having no hard-wired connection between code and thebusiness content layer.

In a similar manner, reports and other output documents exist only inthe metadata created through the Java data management layer. Theseoutput documents are produced by interpreting the metadata and byextracting data from the particular business content chosen. Events maybe set up based on one or more changes in the business content data, butprocessing of an event depends on metadata that defines the event.Processing steps can be created to summarize and “filter” data,depending upon the metadata defining the summarization and filteringtechniques. Data can be imported from, and exported to, other systemsbased on metadata definitions of data structures.

With reference to inputs, outputs, processing and events, the metadatadefines how the system should respond. The metadata can also be changedby an advanced user. Normal programming steps are decomposed into piecesthat can be combined by a non-programmer into a coherent set ofprocedures that define a unique system.

Using the Java data management layer, an end user can enter data intothe business content layer using forms tailored to the user's specifictask(s). The end user sees specific menus, forms and reports thatpertain to the user's work. Alerts, based on selected triggerconditions, are received by e-mail or screen messaging, reminding theuser of tasks to be performed, relevant training and relevant eventsthat have occurred. An end user cannot affect the business contentlayer, except in assigned areas, so that data are secure while beingaccumulated. A user located in a remote site, connected by telephone orthough the Internet, can provide input information for a company'ssystem using the Java data management layer.

A manager who uses the system can see high-level, cumulative dataconcerning a relevant area in the business content layer and can move tothe level of detail needed for the task at hand, including charts andgraphs accumulated over time for monitoring a business area. Throughevent management, a business can be alerted, by e-mail, facsimile orscreen message, to trends that are especially relevant to that businessarea.

The Java data management layer and the metadata layer together serve asa standard interface system that is positioned “on top of” one or moredatabases, allowing addition, deletion and modification of data entryforms, tables, views, images, reports, queries, information processingand logic, monitoring or work flow and distribution and routing, menupresentations and provision of regulatory or non-regulatory alerts.Substantially all of the data entry and modification, report monitoringand preparation, and other monitoring processes are transparent so thatthe user need not be a computer programmer to deal with changes thatoccur from time to time.

E. Change Management Layer

The change layer primarily involves an intranet or the Internet and usesone or more intelligent agents (IA's) that continually search on the Webfor relevant changes in a selected business area. The changes may beregulatory and/or non-regulatory, and each IA is defined by rules andconstraints that focus on the selected business area. When an IAdiscovers a relevant change, the IA obtains all available informationconcerning this change and delivers this information to the Java datamanagement layer. A user may configure the system to apply pre-definedrules to the change in order to determine whether the change informationdelivered by the IA will be accepted and acted upon by the Java datamanagement layer. Alternatively, the user may decide manually (ormanually override the pre-defined rules) whether the delivered changeinformation will be accepted and acted upon, or ignored.

Assume that a data entry form is to be created based on the DepartmentTable of the invention. FIG. 6 is a flow chart showing the steps used toaccomplish this. In step 101, the Form Builder function is launched fromthe Tools Menu. In step 103, the form is given a name, and theDepartment Table is selected as the base table. In step 105, one or morefields are chosen for incorporation in the data entry form, and the formis uploaded to the network. A maximum of three steps is required tocreate a data entry form using the invention. The data entry form andits definition may be assumed to be bug-free, because the underlyingForm Builder has been thoroughly tested and confirmed to generate thecorrect metadata definition of the desired form.

This approach should be compared with the flow chart in FIG. 7, showingthe procedure for creating the same data entry form in a conventionallanguage-based development environment. In step 111, the language-basedenvironment development tool is invoked. In step 113, the program codeis written and debugged. The program is compiled, in step 115, and anexecutable is generated, in step 117. In step 119, the executable isplaced in the appropriate directory on all user desktops in theorganization. Additional steps are required to create a new data entryform, using a conventional approach, and steps 113 and 115 should berepresented as a loop, because it is unlikely that the new program codewill compile and run the first time.

The invention is preferably implemented in software and, as noted in thepreceding, has been reduced to practice using a Java programminglanguage and using a relational database system such as Oracle to createlinks between the different components of the software package. In oneembodiment, the system is expressed as seven interacting menus (File,Logic, Distribution, Data, Tools, Administration and Help), each withsupporting functions, in the following format and with the followingfunctions

I. File Menu

A. WorkList

1. WorkMap

2. WorkCalendar

3. WorkChat

4. WorkList Help

B. Data Entry Forms

1. Image/URL

2. Video/Audio

3. Form Report

4. Copy Record

5. Archive Record

6. Find Data

7. Calculate Record

8. Form Help

9. Grid Data Entry

10. Related Forms

C. Report

1. Process

2. Edit

3. Preview

4. Report Print

5. Report Send

D. Program

E. Favorites

F. Find

II. Logic Menu

A. Calculator

B. Process

1. Run Process

2. Schedule Process

C. Intelligent Agent

D. Graph/Chart

III. Distribution Menu

A. Alert Messaging

1. Alert History

2. Conditional Alerts

B. Send To

C. EDI

IV. Data Menu

A. Import

B. Export

C. Archive

D. Copy

WebLinks

V. Tools Menu

A. New Form Builder

B. Edit Form

1. Form Properties

2. Link To

3. Item Properties

4. Display Items

5. Formula Items

C. Edit Form Items

D. Event Builder

E. Report Builder

F. Document Builder

G. Delete Module

H. Formula Builder

I. View Builder

J. Advanced Query Builder

K. Intelligent Agent Builder

L. Set Up Processing

M. Set Up WorkList

N. Maintain Parameters

VI. Administration Menu

A. Set Up Distribution

B. Maintain Distribution Groups

C. Maintain Menu

D. Maintain Server Process

E. Security

F. Change Password

G. Maintain Functional Versions

VII. Help Menu

A. Help System

B. Help Desk

C. About Change Agent System

Content and purpose of these functions are discussed in the following.

I. File Menu

A. User WorkList is a task-driven function that a user creates tosupport the user's own internal business processes. WorkList isintegrated with other functions in the framework and can be used tolaunch entry forms, reports, processes, tools, URLs, Web pages andexternal programs. The integrated function of WorkList include thefollowing.

1. WorkMap is an integrated business process management and routingfunction that implements user tracking of the status of a task, receiptof new tasks, and routing of tasks to other users. WorkList can beviewed as a workflow activity by enabling the WorkMap option. WorkMapdata can be viewed on-line, printed, or transmitted using e-mail andfacsimile.

2. WorkCalendar provides an integrated calendar view, by day, week,month, calendar quarter, calendar half or year, of all tasks in a workflow activity, of a work flow activity in a graphical format. Calendarinformation can be viewed on-line, printed or transmitted by e-mail andfacsimile.

3. WorkChat is an integrated on-line chat function, allowing a user toselect a chat channel and to work privately or with a selected group tosolve task-related problems.

4. WorkList Help is an integrated function providing amplifyinginformation concerning an activity or requirement.

B. Data Entry Form implements manual data entry into the system, as wellas querying, calculating with and analyzing entered data. Data EntryForm provides function for navigating to attached images, to Web pageURLs and to subsidiary forms. The integrated function of Data Entry Forminclude the following.

1. Image/URL implements attachment of document images and Web page URLs(“Images”) to business records. A user can open an Image, view the Imageon-line, print the Image and transmit the Image by e-mail and facsimile.

2. Video/Audio implements attachment of video and audio clips tobusiness records. A user can launch a video or audio image, print videoimages, and send video and audio clips by e-mail and facsimile.

3. Form Report implements creation of one or more reports from a basetable(s) used by the form. A user can preview, print and send a reportsby e-mail and facsimile.

4. Copy Record implements copying data from one record to another. Auser can create multiple copies and can copy a record from a childrecord by selecting the relevant table(s) and column(s) to be copied.

5. Archive Record implements archiving, de-archiving, purging andviewing of one or more records.

6. Find Data implements finding of one or more records based onparent-child relationships. A user can search for and view a record byentering an “or like” condition for any column in any parent or childtable.

7. Calculate Record attaches pre-defined mathematical formula (s) to aform and calculation of results using the formula (s). A user can mapformula arguments (variables, parameters) to tables and columns in adatabase, read in transaction data imported from external systems, setup data profiles to reduce data entry, and enable creation of newrecords based on calculated results. Results can be graphed, printed ortransmitted by e-mail and facsimile.

8. Form Help provides form and field level help on-line.

9. Grid Data Entry implements querying and editing of records in a gridor spreadsheet-style interface. A user can transmit grid data by e-mailand facsimile.

10. Related Forms implements launching of a sub-form or related formfrom a master form.

C. Report implements viewing, printing and transmitting data based onpre-defined business requirements. Data are provided to a user in themost useful format for that user. A data report can be in tabularformat, with column(s) displayed horizontally, in columnar format, withdata displayed vertically, or in document format, with data inserted ontop of, or associated with, regulatory form images. Indeed, thisassociation is a key feature of the invention. A report functionincludes the following features.

1. Process implements processing the results of the report. This featureis used for more complicated reports, where logic or multiple datasources (Tables, Views, etc.) may be involved. A user can define one ormore parameters, such as location, date or period, to filter the resultsof the process.

2. Edit implements user editing of a report, either directly or throughselection and use of data entry forms supporting the report.

3. Preview implements previewing report results in tabular, columnar anddocument formats. A user can also scroll through multiple pages androws. A graph, attached to a report, can also be previewed.

4. Report Print implements printing the results, and any associatedgraphs and other attachments, of a report.

. Report Send implements transmission of a report, including graphs andother attachments, by e-mail and facsimile.

II. Logic Menu

A. Calculator implements calculation of results using pre-definedformulas. A user can enter values for formula arguments, calculateresults, view the results on-line, print the results and transmit theresults by e-mail and facsimile.

B. Process is a menu for the following process features.

1. Run Process implements processing of results for a report andanalysis tasks, such as statistical analysis of data. This function isused for more complicated reports, where logic or multiple data sources(tables, views, etc.) may be involved. A user can define one or moreparameters, such as location, date or period, to filter the results ofthe process, can export result data, and can open reports that are basedon the result data.

2. Schedule Process implements launching of one or more intelligentagents and background processes. This function implements scheduling ofprocesses (e.g., reporting) in advance, in order to limit disruptionsthat can occur in normal system operations.

C. Intelligent Agent launches one or more intelligent agents (IAs) topursue internal and external Web activities. An “intelligent agent” is aspecialized program that makes decisions and performs tasks based onpredefined rules and objectives. An IA can be used to identify changesin laws, statutes, ordinances, regulations and related issues, changesin technical requirements, to provide feedback, and to perform ChangeConfiguration tasks.

D. Graph/Chart implements opening of a graph or chart, based on apre-defined data set, to provide line, bar, pie, stacked area charts andother charting formats. A user can manually manipulate depth, rotationand elevation of graph and chart results, can print the results and cantransmit the results by e-mail and facsimile.

III. Distribution Menu

A. Alert Messaging implements transmission of alert messages by screen,pager, e-mail and facsimile. A user selects an alert mode, specifies anexpiration date and time, selects one or more recipients, selectsmanual/send for the alert, views an alert history and/or sets up one ormore alert conditions that will automatically trigger the sending of analert. Alert Messaging includes the following function.

1. Alert History implements viewing of one or more alerts that have beentransmitted, according to content, recipient(s), sender, date and timeof transmission, message and other relevant criteria.

2. Conditional Alert implements setup of automatically triggered (asdistinguished from manually triggered) alert conditions, according toalert mode, description of triggering event, message, recipient(s) andconditional logic.

B. Send To implements transmission of documents and associated imagesthrough e-mail and facsimile. A user can select a document to be sent,mode of transmission, recipient(s), and the return pager number forconfirmation. A user can look up distributions of historic documents byspecifying document name, recipient(s), sender, date and time oftransmission, message and other relevant criteria.

C. EDI implements transmission of data by electronic data exchange(EDI). A user can specify transaction data being sent, recipient(s),other information describing the transaction, and can then transmit thedata.

IV. Data Menu

A. Import implements importation of data from external files. A user canselect files for import, select tables as import destination(s), definedelimiters and text qualifiers, separate fixed width columns, mapexternal file fields to database columns, define lookup conditions,parse conditions, check for errors and import data.

B. Export implements export of data to external files. A user select'sthe file(s) to be exported, the table(s) to be exported, the delimiterand text qualifier, sets up file and column properties, checks forerrors and exports the file.

C. Archive implements archiving, de-archiving and purging of data. Auser can enable or disable an archive, recover archived data, purgedata, recover archived data and create snapshots of archived data.

D. Copy implements copying of one or more records within a table. A usercan create single of multiple copies and copy data from child records byselecting relevant tables and columns to be copied.

E. WebLinks opens and attaches Web page links to a master Web page. Auser can select, attach, order, remove and launch a Web page from themaster Web page.

V. Tools Menu

A. New Form Builder implements creation of new data entry forms, using achange configuration function. A user can assign one or more new formsto a business area and group, specify the form name, select base tables,select columns, create and display formula columns, format columns andsave the new form.

B. Edit Form implements editing or otherwise changing an existing form,using a change configuration function. A user can select a form, makechanges to a form, save the changes, The Edit Form module includes thefollowing functions.

1. Form properties change of form level (as distinguished from fieldlevel) properties. A user can change a form layout, change the queryfilter condition and specify restrictions on global queries.

2. Link To links related forms to a specified form so that the relatedforms can be launched from Data Entry Form. Here, child forms are linkedto a parent form.

3. Item Properties allows a user to change field level (as distinguishedfrom form level) properties. A user can change the field label, displaywidth, sequence, list of values, lookup form (a form that is edited fora foreign key column) and other relevant properties.

4. Display Items implements addition of display-only fields to a form. Adisplay field can be based on columns from other tables, includingtables that are twice removed from the form's base table.

5. Formula Item adds formulas to existing tables and display-onlyfields.

C. Edit Form Item implements editing of form fields. A spreadsheetformat allows a user to easily re-sequence and edit data for single ormultiple fields.

D. Event Builder implements attachment of form level and databasetriggers to data entry forms

E. Report Builder is a change configuration function for buildingreports based on tables and views (joins of multiple tables).

F. Document Builder is a change configuration function for mappingdocuments, such as regulatory forms, onto to database columns forreports.

G. Delete Module is a change configuration function for deleting dataentry forms, reports, processes and worklists.

H. Formula Builder is a change configuration function for creatingformulas, including complex, nested equations.

I. View Builder is a change configuration function for creating viewsfor use in reports.

J. Advanced Query Builder is a change configuration function forcreating more sophisticated queries and views.

K. Intelligent Agent Builder is a change configuration function forspecifying or modifying rules and objectives to be used by anIntelligent Agent to be launched.

L. Set Up Processing is a change configuration function for creatingcomputational processes using one or more views.

M. Set Up Work List is a change configuration function for setting uptask-driven menus based on data entry forms, reports, processes,subworklists, tools, Web pages and external programs.

N. Maintain Parameters is a change configuration function for creatingand maintaining parameters for use in filtering reports.

VI. Administration Menu

A. Set Up Distribution implements setting up users, printers, facsimilemachines, pagers and other distribution instruments.

B. Maintain Distribution Groups creates distribution groups and assignsusers to these groups.

C. Maintain Menu maintains the system menu, including the menu picks,language, color schemes and other relevant properties.

D. Maintain Server Processes implements connecting to and initiatingserver-side processes, such as e-mail, facsimile, pager and GISprocesses.

E. Security implements setting up user groups, system privileges,database privileges and other relevant security activities.

F. Change Password implements changing of user passwords.

G. Maintain Functional Versions compares and manages data associatedwith functional versions, including changes to data entry forms, views,reports, processes and worklists.

VII. Help Menu

A. Help System provides context-sensitive technical and functional help.

B. Help Desk manages internal and user-related issues.

C. About Change Agent System describes the regulatory change system,including system version information.

The system provides a “business application browser” that combines Webbrowser technology with a selected set of business application itemsthat are common to the tasks to be performed to implement informationmanagement for a given business area or requirement, including commonfunctions such as work/task management, data entry, reporting, dataprocessing and analysis, data presentation (printing, electronicdisplay, distribution, etc.), and report and document preparation.

The invention thus combines the connectivity of a Web browser with thedata management tools for a selected business activity. Because thesystem is, or may be arranged to be, accessed and used through anInternet connection, the system is not limited to stand-alone or localapplications. A business with activity sites throughout the world can beconnected as easily as a group of contiguous sites. The system allows abusiness to use the normal business skills of their employees and doesnot require that every employee become a programmer in order to continueto respond to regulatory and/or technological and/or social changesaffecting business operations and/or information managementrequirements.

As examples of applications which are enabled by the invention, an EH&Ssystem and an FDCMTD system are developed and discussed subsequently.

In the EH&S area, for example, the business content layer in oneembodiment may include seven sections that communicate with each otherthrough a mechanism that integrates these sections:

(1) product stewardship, including product information, ecological andtoxicological studies, allegations/inquiries tracking, MSDS managementand materials and waste labeling;

(2) incident tracking and prevention, including emergency management,incident tracking and process safety;

(3) personnel health and safety, including personnel demographics,personnel training, safety, injuries and illnesses, industrial hygieneand occupational medicine;

(4) hazardous materials and waste, including hazardous materials, wastetracking, pollution prevention and site remediation;

(5) environmental releases, including air emissions, water discharges,soil and groundwater discharges and toxic chemical releases;

(6) regulatory requirements, including audits, regulatory lists,regulatory issues, requirements and litigation;

(7) facilities management, including physical and organizationalstructures, company information, equipment tracking and process andoperations information; and

(8) tools that allow one to implement the EH&S functionality.

In an area such as food, drugs, cosmetics, and medical treatments anddevices (“FDCMTD”), a business content layer may include activities orobjects in one or more of the following seven areas and implementcommunication between the areas:

(1) foods, food additives, prohibited food additives, animal feeds,labeling, packaging, testing on animals and humans, unavoidablecontaminants, nutritional guidelines, dietary supplements, irradiatedfoods;

(2) drugs and pharmaceuticals, advertising, labeling, packaging,prescription forms and orders, drug names, interpretative statements andwarnings, bioavailability and bioequivalence, controlled substances,controlled substance schedules, narcotic treatment drugs, medicatedfoods and feeds, over-the-counter drugs, applications for FDA approvalof new and modified drugs;

(3) animal drugs and feeds, labeling, packaging, unavoidablecontaminants, oral, implantable, injectable, ophthalmic, topical andintramammary dosages, tolerances, feed additives, feed irradiation,prohibited substances;

(4) cosmetics, labeling voluntary registration and filing ofingredients, warning statements;

(5) biologics, registration and product listing, use of blood and bloodcomponents, diagnostic substances;

(6) radiological treatments and devices, records and reports,notification of defects, repurchase, repair and replacement ofelectronic products, import controls, performance standards forelectronic products, ionizing radiation emitting products, microwave andradiofrequency emitting products, light emitting products andsonic/infrasonic/ultrasonic radiation emitting products; and

(7) medical devices, clinical chemistry and toxicology devices,labeling, device corrections and removals, recalls, premarketingapproval, tracking and classification of devices, exemptions, cigarettesand smokeless tobacco, banned devices.

These areas are complemented by tools that allow one to implement theFDCMTD functionality.

In connection with FDCMTD activities, the primary considerations mayinclude: (1) which FDCMTD items are now part of inventory, and whichFDCMTD items need to be replenished; (2) by what other names, if any, isan FDCMTD item known in the trade; (3) what restrictions on labelingand/or packaging of an FDCMTD item are imposed; (4) what restrictions,if any, are imposed on animal testing of each FDCMTD item; (5) are testresults for an FDCMTD item presently being evaluated by a federal orstate agency (e.g., the FDA or the NRC); (6) does dispensing of aparticular FDCMTD item require licensing or certification of thedistributor by a federal or state agency; (7) what are the expirationdates, if any, for each FDCMTD item in inventory; (8) what are therestrictions, if any, on use, dermatological application or ingestion ofeach FDCMTD item in inventory; (9) which FDCMTD items, if any, areconsidered experimental and may not be distributed to any recipientswithout restriction; (10) which FDCMTD items require presentation of aproperly executed restriction form before the item can be dispensed; and(11) which FDCMTD items are subject to control by a federal or stategovernment. These and related questions are incorporated in data entryforms, analysis result forms, report and other document forms, anddistribution forms for a business area that includes part or all of theactivities that involve one or more FDCMTD items.

A similar integrated set of sections can be developed in any of theother regulated areas to which one or more of the Codes of FederalRegulations applies, or selected areas of non-regulatory change in abusiness activity. The system uses the four interacting software layers(change, Java data management, metadata and business content), discussedin the preceding, and may include an array of pre-defined documentforms, report forms, data entry forms, formulas and calculations thatare most likely to be needed in that business activity. Thesepre-defined forms and analytical procedures are changed or supplementedto meet the relevant regulatory and non-regulatory changes that areidentified by one or more Intelligent Agents that reside on a network,such as the Internet, and that are identified and entered manually byindividual users. System functionality can be extended by importingrelated analytical techniques, such as geographic information systemscapability, and by use of internet links to expand the flexibility ofthe system.

An EH&S system that implements the invention in one embodiment includeseight sections, illustrated in an example shown in FIGS. 8-19. Each E&Ssection has several functional modules that are responsible fordifferent activities associated with tracking and creating reports onrelated activities and for providing links between the different modulesin the same section and/or in another section. The sections and theinput data and output data for these sections are as follows.

I. Product Stewardship

Input data:

material/chemical information

product information

MSDS management

product labeling

ecology/toxicology studies

pesticide information

computer usage tracking

allegations/inquiries tracking

Output data:

material technical sheets

vendor/outbound ANSI MSDS information

products, products-in-process and waste labels

risk assessment studies

FIFRA labels and reports

TSCA labels and reports

customer usage surveys

allegation/inquiry reports

II. Incident Tracking and Prevention

Input data:

emergency management

incident tracking

material/waste spills

near-miss tracking

hazards analysis and modeling

workplace safety

process safety management (PSM)

Output data:

emergency plans

emergency resources and mutual aid

incident notifications and agency reports

safety inspection reports

safety audit reports management of change reports

PSM and project review reports

III. Personnel Health and Safety

Input data:

personnel information

personnel demographics

training plans

injury and illness tracking

workers compensation and disability events

industrial hygiene (IH)

occupational medicine epidemiological trend analysis

Output data:

personnel profiles and histories

personnel locations and personnel protection equipment (PPE) use

training reports

OSHA and internal injury/illness reports

workers compensation and disability reports

IH monitoring, plans and reports

medical screening reports epidemiological studies

IV. Hazardous Materials and Waste

Input data:

materials management

shelf life tracking

waste stream information

waste manifesting

waste accumulation and storage

on-site waste treatment and disposal

hazmat and waste labeling

pollution prevention

site remediation

Output data:

SARA state/local inventory reports

shelf life reports

vendor and internal waste profiles

manifests, LDR and exception reports

EPA hazardous waste reports

waste facility permit applications

NFPA/HMIS waste labels

waste minimization reports

V. Environmental Releases

Input data:

air emissions

water discharges

leak detection and repair

emission reduction credits

soil discharge and stormwater monitoring

groundwater and water quality

toxic chemical releases

permit management

permit conditions and exceedence monitoring

Output data:

air emission inventory and fee reports

LDAR reports

emission reduction reports

discharge monitoring reports

groundwater sampling reports

toxic release inventory reports

permit applications and compliance reports

exceedence reports

VI. Regulatory Requirements

Input data:

environmental audits

inspections

requirements management

regulatory issue tracking

compliance and corrective action plans

legislation tracking

regulations

regulatory list management

Output data:

audit reports

inspection reports

requirements reports

company and site issue reports

corrective action plan reports

legislative action reports

regulation profiles

regulatory list tracking

VII. Facilities Management

Input data:

site physical information

site organization information

customer and vendor information

process information

equipment/training information

project and task management

sample tracking

EH&S cost tracking

enterprise reference data

Output data:

site profile reports

customer and vendor reports

process history and operations reports

equipment/training reports

project and task reports

sampling and COC reports

EH&S cost reports

enterprise data lists

VIII. Tools:

data entry form creation

data import/export

custom fields

custom processing

report creation

output from report creation

document creation

query/data view creation

print. facsimile, e-mail paging

alert rules and messaging

imaging

geographic information systems

task management and work flow

on-line help

archiving security

The Product Stewardship section includes databases that provide relevantinformation on chemical and physical properties of materials used at afacility, product handling information, ordinary and special hazardsassociated with a material consumed, processed and/or produced at thefacility, and environmental health and safety (EH&S) assessments. Thissection can create a Materials Safety Data Sheet (MSDS) in a pluralityof languages, using pre-set phrases linked to the EH&S assessments, andthe MSDS can be distributed to selected recipients using the system'sMSDS distribution system (facsimile, e-mail, hard copy, etc.). Thissection permits a user to perform life cycle analyses on selectedmaterials. MSDS image files can be created and stored within the systemand/or can be converted to an ANSI standard 16-section format for HAZCOMviewing. A user can also create HAZCOM warning labels that comply withNFPA and HMIS requirements. This section also tracks material importsand exports, as well as pre-manufacture notifications, ecology-toxicitystudies, allegations received concerning discharges, and inquiriesconcerning manufactured chemicals. This section also provides forpesticide reporting under FIFRA.

The Incident Tracking and Prevention section captures and accumulatesinformation on all environmental releases and discharges and allinjuries and illnesses at the facility. This section includes a listingof incident command structures, listings of qualified emergency responsepersonnel, responsibilities for emergency responders and emergencyprocedures, including checklists. This section identifies hazardsassociated with, and emergency response information for, materials thatmay be released. A Geographic Information System (GIS) tool is includedthat can be used to graphically display incident information, locationsof nearby toxic, reactive, ignitable and/or corrosive chemicals and ofthe closest emergency response equipment. This section provides agencyreportability determination for SARA and CERCLA releases and providesfollow-up notifications for the appropriate agencies. Associatedstatistical tools allow statistical analysis of incidents to identifypossible trends. Environmental releases, permit excursions, injuries andillnesses at the facility can be accumulated for a selected division orfacility or for an entire enterprise to create reports for SARA, OSHAand internal reporting requirements. Incidents that result in workerscompensation issues and/or in risk management issues can also beidentified and tracked.

The Personnel Health and Safety section is the main repository ofemployee information and allows scheduling, monitoring and tracking ofevents involving industrial hygiene, safety and/or occupationalmedicine. All types of industrial health surveys are supported,including chemical, noise, heat stress, radiation and ergonomics.Results of occupational medicine examinations, including physical exams,health history questionnaires, respirator fit tests, EKG exams,audiometric exams, pulmonary function tests, vision tests, x-ray examsand drug screening, can be accumulated and analyzed. This sectioncaptures and accumulates employee demographics, primary and secondaryjob classifications, job activities, and employment histories. Thissection is integrated with other sections to create process surveys andanalysis plans for exposure groups that can be selected by industrialhygiene and safety personnel. This section aids in identification oftraining needs associated with a job, a location or a regulatoryrequirement. Groups of persons that need particular training can beidentified, and content of appropriate training courses and follow-upcourses can be determined. Costs associated with all examinations andtraining activities can be captured and examined.

The Hazardous Materials and Waste section tracks a material's arrival atthe facility, the maximum quantity stored, distribution and use ofmaterial at the facility, movement, and consumption and disposal ofmaterial at the facility. Material tracking provides information tosupport SARA notifications and release reporting and allows a user togenerate waste profiles, hazardous waste manifests and related DOTshipping information. This section maintains a library of previousmanifests, tracks the status of manifest copies, and captures and notesdiscrepancies and modifications, if any, vis-a-vis an earlier manifest.The manifest information, once created, is rolled up to produce RCRAstate and federal waste summary reports. This section also provides forauthorization, stocking, inventorying and re-ordering of material toensure that required materials are always available. Pollutionprevention projects, source reductions, waste minimization and wastetracking against user goals can be implemented within this section tomeet internal and/or external targets. The section provides mass andenergy balance tracking for selected processes and/or selectedequipment.

The Environmental Release section captures necessary data to createagency reports of releases to air, water or other liquids, and land. Airrelease information can be captured for Title V requirements, riskmanagement plans, air emissions inventory summaries, and leak detectionand repair programs. This section captures multimedia permitrequirements for air, effluent discharges, stormwater, water quality andwaste facility permits. Permit dates and imposed conditions can bemonitored using automatic screen alerts or e-mail messages. Tracking ofcalibration events, samples, analysis requests and laboratory reportsare implementable within this section.

The Regulatory Requirements section provides additional tools that areuseful in implementing and managing EH&S compliance, includingidentification of all internal and external requirements in order thatthe facility be allowed to operate. This section also identifies who isresponsible for compliance with a particular requirement. This sectioncan be used to determine if, and how, proposed regulations will affectfacility operations by providing access to material, equipment andprocess information to which the regulations may be applied. Referenceinformation, such as checklists and current regulations, are availablethrough this section or by use of links to Internet data sources.Compliance documents, interpretations, procedures and work plans can bestored and shared with all affected persons and organizational units.The status of work plans, tasks and activities can be tracked andreported. Audit scheduling, audit findings and corrective actionsscheduled and implemented can be identified and reported to providefeedback on the effectiveness of the facility's compliance program. Thissection provides an effective tool for designing and implementing an ISO14000 compliance program for a facility.

The Facilities Management section is a cross-functional sub-system thatmaintains site-specific and enterprise data. This section capturesgeographic information, organizational structures, equipmentspecifications, operating information, calibration requirements,maintenance schedules, vendor information and user-defined checklists.This section also captures relevant process information and data, sitedisposal activities, products manufactured, unit operations, andsimulation of process scenarios and recipe information. A user canprofile land use wildlife resources and cultural resources present, andsensitivity of selected receptors. This information can be presentedspatially, if desired, using the GIS capability.

FIG. 8 is an image of a screen showing the invention with an EH&Sbusiness solution, referred to as “GreenSuite”, enabled in the mainmenu. FIG. 9 shows the business groups for a business area within theEH&S business solution. FIG. 10 shows an example of a WorkList. FIG. 11shows an example of a configuration tool used to create WorkLists. FIG.12 shows an example of a data entry form. FIG. 13 shows an example of aconfiguration tool used to create data entry forms. FIG. 14 shows anexample of a report. FIG. 15 shows an example of a configuration toolused to create reports. FIG. 16 shows an example of processing results.FIG. 17 show an example of configuration tool used to create dataprocessing. FIG. 18 shows an example of a document. FIG. 19 shows anexample of a configuration tool used to create documents.

In summary, the system accepts new data and forms and changes toexisting data and forms, determines links of each entered data item toone or more of the sections and modules within a section, adds the dataitem to, or uses the data item to upgrade an extant data item within,one or more modules, and implements any quantitative or qualitativechanges that should be made in the remainder of the system as a resultof entry of the data item.

The system also provides tools, including formulas, algorithms,functional descriptions and presentation formats that use one or morealready-entered data items to compute or obtain one or more values thatcan be (1) presented as an output value for a report or otherpresentation on facility operations and/or (2) used to determine whetherthe facility complies with relevant regulations and/or (3) used toindicate an affirmative response corrective action to be taken oralready taken in facility operations.

Closing Comments

This Appendix provides definitions for various objects used in theinvention.

The invention in one embodiment uses a “thin client” approach in aclient/server mode, in which a relatively unsophisticated client serverat the user's site is connected through the Internet or another networkto a server that provides one or more databases of information andprovides substantially all of the analysis and processing capability forthis information. A client or end user enters certain characteristics ofinformation that the user wishes to obtain or process, and the serverhelps the user to build one or more queries that present the request tothe database(s) in a form the database(s) can respond to provide all theinformation the user has requested.

This “thin client” approach allows the combined server/client system totake advantage of the separate strengths of the server (simple and/orcomplex database structures, use of on-line transaction processingtools) and of the client (use of GUI, Windows and Windows applications)without requiring unnecessary duplication of these capabilities. Afterthe user has disconnected from the server, no server programs remain onthe user's terminal This approach requires only modest user terminalcapabilities (20 Mbytes of hard drive space, 8 Mbytes of RAM, a PC orMacintosh or Sun terminal with a mouse, Netscape Navigator 4.1+ orInternet Explorer 4+) and TCP/IP communications capability. The serveror host terminal provides all of the database capability and most of theprocessing power and preferably includes a database structure such asOracle 7.3+, 2 Gbytes of hard drive space, 256 Mbytes of RAM and TCP/IPcapability.

Introduction of some definitions is appropriate here. A “database” is acollection or group of objects that holds various related informationitems. This information is divided into tables, views, columns and rows,and an object is identified by its name and/or icon in a database.

A “table” is a structure that holds data in a database, often as one ormore two-dimensional structures divided into rows and columns. Anexample of a table is a spreadsheet. A table is often referred to as aphysical file.

A “view” is an alternative representation of data in a table and mayappear as one or more columns and/or one or more rows. The dataattributes can change according to the format in which a view ispresented. A view may be an overlay of a table structure but does notreplace the table. A view is often referred to as a logical file.

A “base table” is a table that is referenced in a view or a query.

An “image” refers to a document image on a screen or a Web page that canbe called up and viewed, printed, transmitted and attached to a relevantbusiness record.

A “parent” table, view or form may provide information that is useddirectly to help construct or supplement a corresponding “child” table,view or form.

A “column” is one or more vertically oriented parts of a(two-dimensional) Table and is identified by specifying specificinformation in a table. Each column will have one data type (character,decimal, hexadecimal, integer, alphanumeric, etc.). A row-columnintersection is often referred to as a field.

A “foreign key column” is a column whose data source is a parent primarykey column.

A “row” is one or more vertical parts of a Table and consists of aselected sequence of values drawn from one or more columns—one value foreach column. Row entries are actual data in a table. A row is oftenreferred to as a record.

A “query” is a request to select, format and process/analyze one or morerows of data in a table and can operate on one or more tables. A querymust specify (1) where the requested data are stored, (2) what are thecommon elements, if any, of the tables and/or views to be searched, (3)what data item(s) (usually, one or more columns) the user wishes toselect, and (4) what criteria are applied to a data item. A queryprovides reporting Capability and processing/data analysis capability,using spreadsheets and other tools.

A “query editor” receives a user request and takes the user through allsteps required to build a query to which the system can respond. A querydefinition is created in Structured Query Language (SQL). A query editorstores the information needed to create an SQL statement.

A “query filter condition” is a method for applying restrictions on dataretrieved by a query.

A “trigger event” is an action performed by a user of the system thatinitiates another action or set of actions.

A “form level trigger” is part of a form application and is activatedonly when a specific trigger point is executed with the formapplication.

A “stacked area chart” is a bar type chart in which different datacomponents are displayed as separate regions on a single, vertical orhorizontal bar.

A “report filter” is a method for applying restrictions on the dataretrieved by a report.

A table “join” reassembles the data that appears in a full row, usingcommon columns that exist in two or more tables to associate the data.Stated more abstractly, a table join expresses a relationship betweentwo or more rows of data in logically distinct tables.

An “innerjoin,” also referred to as an “equal join,” is the most commonjoin type, returning or associating rows that match between commoncolumns in two or more tables. An “outer join” returns or associates allrows in two or more tables, whether or not the rows match.

A “direct join” occurs when two or more Tables being joined togethershare a common column. An “indirect join” occurs when two or more tablesbeing joined together do not share a common column; in an indirect join,one or more intermediate tables may share one common column with onetable being joined and share another common column with another tablebeing joined.

When a table join is created between a first table and a second table,the relationship created between the two tables may be one-to-many, witheach record in the first table being unique, and with many correspondingrecords in the second table. This is the preferred data representationand provides accuracy. An alternative relationship, usually undesirablebecause of the possibility of duplication, is many-to-many, in which atleast one record in each of the first and second tables is not unique.For example, multiple records in the first table may match multiplerecords in the second table.

An “expression” applies specified operations to data and defines rowselection criteria, for example, by determining which rows of data willbe returned in response to a query.

A “parameter” is a procedure created within the system to return a valuein response to a query. For example, a parameter may be created toreturn a location name, a threshold value of some variable, or a begindate or end date. A parameter may be changed each time the (same) queryis executed. A value, to be returned to the requester, may be placedinto a parameter in either of two ways: (1) a default value is enteredand (ii) a value is entered after the associated procedure is run. Avalue is entered into the parameter at process run time, and this valueis used (1) to define a new result column or (2) in an expression, todefine one or more selection criteria for the number of rows returned bythe query. A result column applies specified operations to data andreturns a new column of data. An SQL function and arithmetic operatorscan be used to create a result column. A result column can be used toprovide several data types, including calculated values, summary valuesand data processing values.

An SQL function performs operations on data and returns specific valuesbased on the results of those operations. An SQL function may be appliedto a unique data type, such as numeric, alphanumeric, character or datedata, or may be used in a query definition to define a result column oran expression. A SQL function may be used in a query definition todefine a result column or an expression.

Arithmetic function processing manipulates numeric data, for example, byperforming arithmetic, logarithmic, trigonometric and/or statisticaloperations. String function processing manipulates alphanumeric data,including the operations of combining, extracting and movement ofcharacter locations. Data function processing manipulates date data toperform, for example, delay time arithmetic. The arithmetic functionsinclude summation, subtraction, formation of an absolute value and of atrigonometric value for a numeric data item. A string function combinesa plurality of strings, to form concatenated expressions, and extractsone or more characters from a string.

A “set function” groups data according to common values and returns asingle summary row. A set function determines the values returned for aresult column

Date operations, one of the most common uses for a result column,include (1) conversion of date data into a desired format (such asMM/DD/YYYY), (2) conversion of string data into a date value,calculation of days remaining in a given month, and (4) calculation ofthe date and day one year ago. Date processing involves conversion ofcolumn values to a formatted date string, including specification ofcentury (CC, SCC), year (SYYY, YYYY, YEAR, SYEAR, YYY, YY, Y), quarter(Q), month (MONTH, MON, MM, RM), day (DDD, DD), starting day of the week(DY, D), same day of the week as first day of the year (WW) and same dayof the week as first day of the month (W).

The system also employs the Boolean connectives “AND” (in which bothconditions must be satisfied in order for a row to be included in theresult set), “OR” (in which, if either of the conditions is met, a rowis included in the result set) and “GROUP” ( ) which organizes databetween the parentheses for processing.

A database developer usually has several design goals, including (i)maximization of the amount of database information available and (ii)minimization, if not elimination, of duplication of information in thedatabase. These two goals are sometimes at odds with each other. Atypical database will have multiple tables, chosen to help achieve thegoal of minimum duplication. This minimum duplication goal is sometimeshelped by breaking a full row of data into separate tables.

It is claimed:
 1. A system comprising a server system accessible by abrowser executed on a client device, the server system including a firstportion, a second portion, a third portion, and a fourth portion; thefirst portion of the server system having information about uniqueaspects of a particular application including data representative ofstructures and functions associated with the particular application; thesecond portion of the server system having information about userinterface elements and one or more functions common to variousapplications including the particular application; the third portion ofthe server system being configured to dynamically generate afunctionality and a user interface for the particular application, thefunctionality and the user interface of the particular application beingbased on the information in the first portion of the server system andthe information in the second portion of the server system; the thirdportion of the server system being configured to send the functionalityand the user interface for the particular application to the browser;the fourth portion of the server system being configured toautomatically detect changes to metadata of the particular applicationand cause the user interface elements that affect the particularapplication to be modified accordingly.
 2. The system of claim 1 whereinthe information of the first portion of the server system includes atleast one of business knowledge, logical designs, physical designs,physical structures, and relationships associated with one or morepredetermined business applications.
 3. The system of claim 1 whereinthe information of the second portion of the server system includes atleast one of tools, worklists, data entry points, reports, documents,processes, formulas, and images.
 4. The system of claim 1 wherein thethird portion of the server system is configured to provide a set ofinstructions to the client device, the set of instructions beingassociated with at least one of the functionality or the user interfaceof the particular application, the set of instructions configured to beexecuted on the client device, the set of instructions configured tocommunicate information associated with at least one of the firstinformation or the second information.
 5. The system of claim 1 whereinthe fourth portion is further configured to automatically cause thefunctionality to be changed accordingly with the detected changes.
 6. Asystem comprising: a server computer system; a first layer associatedwith the server computer system containing information about the uniqueaspects of a particular application, including data representative ofstructures and functions associated with at least the particularapplication; a second layer associated with the server computer systemcontaining information about the user interface and functions common toa variety of applications including the particular application, theparticular application being generated based on the data in both thefirst and second layers; a third layer associated with the servercomputer system that retrieves the data in the first and second layersin order to generate the functionality and user interface elements ofthe particular application; and a fourth layer associated with theserver computer system that automatically detects changes to metadata ofthe particular application and causes the functionality of theparticular application as defined in the first layer to be modifiedaccordingly.
 7. The system of claim 6 wherein the third layer furthercomprises a data management layer having software instructions fordistributing one or more applets to client computers wherein the appletsdynamically generate and present the user interface and functionality tothe user based on the first and second layers.
 8. The system of claim 6wherein the change management layer further comprises one or moreintelligent agents that detect changes in the metadata.
 9. The system ofclaim 6 wherein the fourth layer automatically causes the user interfaceof the particular application as defined in the first layer to bechanged accordingly with the detected changes.
 10. A method forgenerating applications using a server computer system, the methodcomprising: storing in a first layer information about the uniqueaspects of a plurality of applications including data representative ofstructures and functions associated with at least one of theapplications; storing in a second layer information about a userinterface and functions common to the applications; using the data inthe first and second layers to generate a functionality and a userinterface for the one of the applications; automatically detectingchanges to metadata of the particular application and automaticallymodifying the first layer based upon the changes; and causing the userinterface of the particular application to be dynamically re-generatedeach time a client establishes a connection with the server computerbased upon the data in the first layer and the data in the second layer.11. The method of claim 10 wherein the first layer comprises a businesscontent database storing the information.
 12. The method of claim 10detecting changes is by one or more intelligent agents.
 13. A serversystem for generating an application comprising: a first layercontaining information about the unique aspects of a particularapplication; a second layer containing information about the userinterface and functions common to a variety of applications includingthe particular application, the second layer further including metadatarepresentative of structures and functions associated with at least theparticular application; a third layer that retrieves the data in thefirst and second layers in order to generate functionality and userinterface elements of the application; a change management layer forautomatically detecting changes to the metadata; a first portionconfigured to generate a particular application based on the first andsecond layers upon connection by an authorized client computer; and asecond portion configured to distribute the user interface andfunctionality of the particular application to the authorized clientcomputer.
 14. The server system of claim 13 wherein the third layerfurther comprises a data management layer configured to distribute oneor more applets to the authorized client computer wherein the appletsdynamically generate and present the user interface and functionality tothe user based on the first and second layers.
 15. The server system ofclaim 13 wherein the second layer comprises a metadata databasecomprising data about the structures and functions associated with anyof the variety of applications.
 16. The server system of claim 15wherein the metadata database further comprises data about the userinterface including one or more of tools, worklists, data entry forms,reports, documents, processes, formulas and images.
 17. The serversystem of claim 13 wherein the change management layer further comprisesone or more intelligent agents that detect changes to the metadata. 18.The server system of claim 13 wherein the fourth portion is furtherconfigured to automatically cause the functionality to be changedaccordingly with the detected changes.